Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Albuminuria Clinical Trial

Official title:

Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498116
• Other study ID #: 22-1027
• Status: Recruiting
• Phase: Phase 4
• Start date: January 26, 2023
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Jessica Kendrick
• Phone: 3037244837
• Email: Jessica.Kendrick[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• Type 1 diabetes for at least 5 years

• Urine albumin to creatinine ratio 30-5000 mg/g on first morning void

• eGFR 30-89 ml/min/1.73m2 at time of screening

• Blood pressure <140/90 mm Hg prior to randomization

• Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks

• BMI < 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients).

• Stable anti-hypertensive regimen for at least one month prior to randomization

• Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization

• Sedentary or recreationally active (=2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)

• Able to provide consent

Exclusion Criteria:

• Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year

• Uncontrolled hypertension

• Factors judged to limit adherence to interventions

• Anticipated initiation of dialysis or kidney transplantation within 6 months

• Current participation in another research study

• Pregnancy or planning to become pregnant or currently breastfeeding

• Allergy to aspirin

• Severe hepatic impairment (Child-Pugh Class C)

• History of major psychiatric disorder

• Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)

• Penicillin allergy

• Iodine allergy

• Shellfish allergy

• Current use of phenobarbital, rifampin or carbamazepine

Related Conditions & MeSH terms

• Albuminuria

Intervention

Drug:
• Montelukast
10mg daily

Other:
• Placebo
1 capsule daily

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Albuminuria	Change in albuminuria from baseline to 6 months	Baseline, 6 months
Secondary	Change in Brachial artery flow mediated dilation (FMD)	Change in FMD from baseline to 6 months	Baseline, 6 months
Secondary	Change in Large Elastic Artery Stiffness	Change in aortic pulse wave velocity from baseline to 6 months	Baseline, 6 months